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Originally published March, 1998
Editor's Page
Payback's a . . .well, you know
Performing the tasks that a regulatory agency must perform can't be a whole lot of fun. It's difficult for me to imagine, for instance, that FDA personnel enjoyed the past couple of years, when their every idea was subjected to intense scrutiny—and sometimes rabid criticism—from Congress, industry, end-users, payers, and consumers alike.
So it probably shouldn't be surprising that the Health Care Financing Administration and the Centers for Disease Control and Prevention have in the past chosen to behave more like administrative bodies than regulatory agencies. After all, being the administrator of the federal government's health-care programs—even programs as complex as Medicare or the Clinical Laboratories Improvement Amendment of 1988—is a role that conveys a much more neutral posture than does the performance of regulatory duties, right?
Well, after this year, maybe not. According to many in industry, this is likely to be the year that CDC and HCFA finally get the attention they deserve—unwanted though it may be.
One reason for this attention is the fact that, unlike FDA, HCFA and CDC do not have highly evolved or sophisticated policies and procedures in place to handle affairs involving manufacturers. Although the two agencies may want to behave like administrators, their decisions can often have even greater impact on manufacturers than those of FDA. Already, one industry group has issued a call for reforms in the way the two agencies administrate CLIA (see story, page 26), and there is reason to believe that still more criticism is on the way.
Another likely subject of industry attention is Medicare reimbursement policy, an area where HCFA is actively exploring new policies and procedures. Speakers at January's Medical Device Executive Forum (Anaheim, CA) agreed that reimbursement is likely to be a major issue for the coming year. According to Dick Martin, president and CEO of Physio-Control Corp. (Redmond, WA) and president of the Medical Device Manufacturers Association (MDMA; Washington, DC), "Reimbursement is now first on the minds of MDMA members." Noting that passage of the FDA Modernization Act of 1997 has "created a positive flow of energy through FDA," Martin expressed cautious optimism for improvement of that agency's regulatory performance during the coming year. "But without reimbursement," he added, "we have no market."
For those seeking to reform these agencies and their policies, the trick will be to do so without creating another level of regulation to which manufacturers must respond. That would certainly be little fun—for anyone.
Steven Halasey
